O&M Halyard recalls

7 official recalls and safety alerts involving O&M Halyard since 2021-12, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with O&M Halyard or the relevant agency.

  1. 2026-06-03
  2. US
    Drugs & medicalClass II

    O&M HALYARD INC recalls Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm.), 48773 (Md.), 48774 (Lg.), 48775 (Xl)

    Nitrile Exam Glove failed to meet specifications chemical permeation performance.

    FDA · DeviceO&M HALYARD INCUS Nationwide distribution in the states of GA, CA, NJ, MA, NY, NC.Official notice →
  3. 2025-09-10
  4. US
    Drugs & medicalClass II

    O&M HALYARD INC recalls Orthopedic Pack, Model: 88041-12 AC2424601B 09/02/2029 Universal Pack, Model: 77165-06 AC2424902B 09/05/2029

    Surgical drape packs may have open seals, which may compromise the sterility of the product.

    FDA · DeviceO&M HALYARD INCWorldwide - US Nationwide distribution in the states of GA, AL, PA and the…Official notice →
  5. 2025-01-29
  6. US
    Drugs & medicalClass II

    O&M HALYARD, INC. recalls Brand Name: HALYARD Product Name: Laparotomy Pack Model/Catalog Number: 88231 Software Version: N/A Product Description: Laparotomy Pack…

    Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

    FDA · DeviceO&M HALYARD, INC.US Nationwide distribution in the states of CO, FL, GA, HI, IA, IL, IN, KS,…Official notice →
  7. 2025-01-01
  8. US
    Drugs & medicalClass II

    O&M HALYARD, INC. recalls O&M Halyard Procedure Mask with SO SOFT* Earloops, Yellow-Disposable surgical mask Product Code: 47117

    Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is printed on the…

    FDA · DeviceO&M HALYARD, INC.NationwideOfficial notice →
  9. 2024-04-10
  10. US
    Drugs & medicalClass III

    O&M HALYARD, INC. recalls HALYARD SURGICAL HOOD, Universal Size, Blue, 300 count (3 x 100)

    Product was mislabeled as a Surgical Cap at its dispenser level.

    FDA · DeviceO&M HALYARD, INC.Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, HI,…Official notice →
  11. 2023-09-27
  12. US
    Drugs & medicalClass II

    O&M HALYARD, INC. recalls FLUIDSHIELD 3 N95 Particulate Filter Respirator and Surgical Mask with SO SOFT* Lining, Orange, size small, Product Code 46827

    One respirator sample failed a filtration efficiency test. This respirator may not provide adequate protection to the user.

    FDA · DeviceO&M HALYARD, INC.US Distribution to States of: FL, GA, IA, IL, MO, MS, NE, OK, TN, TX, WI and…Official notice →
  13. 2021-12-08
  14. US
    Drugs & medicalClass II

    O&M HALYARD INC recalls HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL

    All lots of the glove may discolor and lose elasticity upon aging, resulting in the inability of the user to don the gloves without tearing.

    FDA · DeviceO&M HALYARD INCWorldwide distribution - US Nationwide and the countries of EU/Canada.Official notice →